Gilead Sciences received FDA approval for lenacapavir (Yeztugo), a pioneering HIV pre-exposure prophylaxis (PrEP) that requires only biannual injections. Clinical trials demonstrated near-complete protection with zero infections in a 5,300-participant study, leading to early trial termination. This long-acting injectable PrEP aims to improve adherence over daily oral regimens, with expectations to grow the US market significantly as patents on existing therapies, such as Biktarvy, expire. Gilead plans expansion with yearly formulations under development.